FDA Adverse Event
Other
Summary report: N
MIRAGE LIBERTY FEM SYS LGE-AMER
MDR report key: 1613665
·
Received February 12, 2010
Report
- Report Number
- 3004604967-2010-00010
- Event Type
- Other
- Date Received
- February 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- February 12, 2010
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K063011
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT HAD RECENTLY CHANGED FROM WEARING A NASAL MASK TO A FULL FACE MASK. WITHIN 3 DAYS OF WEARING THE FULL FACE MASK THE PATIENT COMPLAINED OF SEVERE PAIN IN MOUTH RESULTING FROM A LOOSENED TOOTH. RESMED REQUESTED ALL RELEVANT INFORMATION BE PROVIDED SO THAT FURTHER EVALUATION COULD BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE MASK WAS NOT RETURNED TO RESMED AND IS NOT ALLEGED TO HAVE BEEN FAULTY.
Description of Event or Problem · 1
A DME REPORTED THAT THEIR PATIENT'S MASK CAUSED THEIR TOOTH TO LOOSEN RESULTING IN SEVERE PAIN IN MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRAGE LIBERTY FEM SYS LGE-AMER | MIRAGE LIBERTY | BZD | RESMED LTD. | 61301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |